Regulatory News

Vulnerabilities in global Supply Chains: Reasons and possible Solutions

The EU Commission has published a document on a "Structured Dialogue on the security of medicines supply". This document presents the most important results of the analysis of the security of supply and possible measures.

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Annex 1 Final Version - EMA representative to present history and changes at December conference

In addition to the previously announced representatives of the GMP regulatory authorities, the industry and the expert groups, a representative of the EMA has now also confirmed his participation and will talk about the changes of the Annex1, their background and the perspective of the EMA.

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Labeling Requirements for IMPs Amended

The European Commission finally adopted the revised Annex VI to the CTR as regards labelling requirements for IMPs. The amendment eliminates the obligation to include an expiry date on the primary packaging of IMPs in specific circumstances.

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The Whistleblower Directive: State of Implementation

In the EU, the so-called EU Whistleblowing Directive was launched in 2019. However, implementation in the Member States is not entirely uniform.

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Serialization - Version 20 of the Q&As on Safety Features

The European Commission published a new version of the Questions & Answers (Q&As) regarding the safety features for medicinal products for human use. Is it allowed to verify the authenticity of the UI when the product is not in physical possession?

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MHRA (UK) now also a full ICH Member

The United Kingdom (UK) becomes a full member of three international associations, including the International Council for Harmonisation ICH.

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Draft on Labeling Requirements for IMPs Published

With the application of the EU Clinical Trials Regulation some labelling requirements for IMPs have changed, in particular regarding the expiry date. Now an initiative eliminates the obligation to include an expiry date on the immediate packaging of IMPs in specific circumstances.

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EMA tackles the Issue of Remote Batch Certification

EMA has today published a draft question and answer document on the remote certification of batches by the Qualified Person (QP).

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Brexit: Legal Proposals adopted on the Supply of Medicines in Northern Ireland, Cyprus, Ireland and Malta

The European Parliament and Council agree to proposals from the EU Commission to ensure the continued supply of medicines to Northern Ireland, Cyprus, Ireland and Malta. Both a directive and a regulation are now in place.

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News on the various Mutual Recognition Agreements (MRAs)

The new annual report of the GMP/GDP Inspectors Working Group has been published and gives a brief but good overview of what is new in 2021. There has also been movement on the MRA with the USA.

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